Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2023-12-05
2024-05-15
Brief Summary
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* The secondary objective of this study is to gather and analyze ancillary data to confirm the diagnosis or absence of glaucoma.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Pathology
Subjects with glaucoma-affected eyes
TEMPO iMOvifa
Screening test with 28 testing points
Normal
Subjects with healthy eyes
TEMPO iMOvifa
Screening test with 28 testing points
Interventions
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TEMPO iMOvifa
Screening test with 28 testing points
Eligibility Criteria
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Inclusion Criteria
* Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.
* BCVA 20/40 or better in both eyes.
* IOP ≤ 21 mmHg
* Healthy anterior and posterior segment evaluation on clinical examination.
• Diagnosis of glaucoma on clinical examination.
Exclusion Criteria
* History of intraocular surgery (uncomplicated surgeries are accepted).
* Ocular diseases including uveitis, non-glaucomatous optic neuropathy, severe or proliferative diabetic/ hypertensive retinopathy (controlled diabetes and hypertension participants with no or mild to moderate retinopathy \[not involving the macula\] can be included), unresolved trauma.
* Any neurodegenerative diseases including Alzheimer, Parkinson, or dementia, or history of stroke.
* Unreliable VF testing and/or poor-quality OCT scans.
* Poor fixation.
40 Years
ALL
Yes
Sponsors
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Cape Fear Eye Institute
OTHER
Responsible Party
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Principal Investigators
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Christina Jones
Role: STUDY_DIRECTOR
Clinical Research Coordinator
Locations
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Cape Fear Eye Institute
Wilmington, North Carolina, United States
Countries
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Other Identifiers
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CF-2023-01
Identifier Type: -
Identifier Source: org_study_id
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